Study of combination therapy by oral isotretinoin, local clobetasol, and tacrolimus in comparison to local clobetasol, and tacrolimus on patients with Frontal Fibrosing Alopecia
In this single-blind randomised clinical trial 34 patients with FFA will be divided into 2 same group. Inclusion criteria are patients with clinicopathologically proven FFA, older than 18 years and exclusion criteria are 1. pregnancy 2. inability to participate or follow the trial 3. severe hypertriglyceridemia 4. liver enzyme disturbance 5. consumption of immunosuppressant or another kind of LLP or FFA therapies during recent 3 months. in one group combination therapy by oral isotretinoin, local clobetasol, and tacrolimus will be prescribed and in other group local clobetasol, and tacrolimus.before trial entrance and then in 2, 4 and 6 months after the results for both groups will be compared by Frontal Fibrosing Alopecia Severity Index (FFASI) and Fotofinder for hair diameters or density, itching and hiar loss.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091736173N1
Registration date:2017-10-25, 1396/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Hamidreza Mahmoudi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 55630174021
Email address
mahmoudi_h@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of combination therapy by oral isotretinoin, local clobetasol, and tacrolimus in comparison to local clobetasol, and tacrolimus on patients with Frontal Fibrosing Alopecia
Public title
Study of combination therapy by oral isotretinoin, local clobetasol, and tacrolimus in comparison to local clobetasol, and tacrolimus on patients with Frontal Fibrosing Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with clinicopathologically proven FFA, older than 18 years
Exclusion criteria: 1. pregnancy 2. inability to participate or follow the trial 3. severe hypertriglyceridemia 4. liver enzyme disturbance 5. consumption of immunosuppressant or another kind of LLP or FFA therapies during recent 3 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
000000
Secondary trial Id
000000
Registration date
2017-11-22, 1396/09/01
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, School of Medicine
Street address
Tehran, Enghelab Avenue. Tehran University of Medical Siences, school of medicine
City
Tehran
Postal code
Approval date
2017-10-15, 1396/07/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3707
Health conditions studied
1
Description of health condition studied
Frontal Fibrosing Alopecia
ICD-10 code
L66.1
ICD-10 code description
Lichen planopilaris
Primary outcomes
1
Description
Frontal Fibrosing Alopecia Severity Index (FFASI)
Timepoint
before trial and in 2, 4, and 6 months later
Method of measurement
Questionaire
2
Description
hair amount and density
Timepoint
before trial and in 2, 4, and 6 months later
Method of measurement
Fotofinder
3
Description
clinical presentations (itching and irritation)
Timepoint
before trial and in 2, 4, and 6 months later
Method of measurement
Patient asking
Secondary outcomes
1
Description
Perifollicular scaling
Timepoint
before trial and in 2, 4, and 6 months later
Method of measurement
Trichoscope
2
Description
Perifulicular erythema
Timepoint
before trial and in 2, 4, and 6 months later
Method of measurement
Trichoscope
Intervention groups
1
Description
in the first group the first 2 weeks of intervention includes local daily clobetasol for 5 days then local tacrolimus daily for 2 days, at the end of second week the patient will apply local daily tacrolimus for 5 days and local daily clobetasol for 2 days. in the second group the same intervention will be done while oral isotretinoin 20 mg every other day for one month then daily for second month will be ordered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Hamidreza Mahmoudi
Street address
Tehran Province, Tehran, District 12, Vahdat-e-Islami St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmoudi
Street address
Tehran Province, Tehran, District 12, Vahdat-e-Islami St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amini
Position
Dermatology Resident
Other areas of specialty/work
Street address
Tehran Province, Tehran, District 12, Vahdat-e-Islami St
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Fax
+98 55620300
Email
Flipopart@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmoudi
Position
Dermatologist, Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Tehran Province, Tehran, District 12, Vahdat-e-Islami St
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Fax
+98 55620300
Email
mahmoudi_h@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amini
Position
Dermatology Resident
Other areas of specialty/work
Street address
Tehran Province, Tehran, District 12, Vahdat-e-Islami St
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Fax
+98 55620300
Email
Flipopart@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)